The European Commission has made changes to rules governing the provision of electronic instructions for use (eIFU) for medical devices (MDs), as originally laid down in Regulation 207/2012.
The latest update, Implementing Regulation 2021/2226, repealed and replaced Regulation (EU) 207/2012. IFUcare is a pioneer in e-labeling and eIFU services since 2008, and immediately applied the new EU provisions to their services.
Paper IFU and eIFU
IFU and eIFU are essential in ensuring medical devices are used safely. The governing rules require that the level of safety, longevity and security for eIFU is greater than, or at least equal to, those for IFU.
The eIFUs for medical devices are now widely provided, with obvious benefits: a huge reduction of paper waste and costs, and overcoming logistical challenges of paper IFU.
Impact on manufacturer
Manufacturers that want to continue using eIFUs under the MDR framework should review the new Implementing Regulation 2021/2226. The devices that can make use of eIFUs include implantable and active-implantable medical devices, fixed installed medical devices, and devices fitted with a built-in system to display instructions.
New rules
One of the rules introduced in the MDR is that implant manufacturers must also provide implant cards and patient information. IFUcare's eIFU website allows manufacturers to distribute both information for healthcare professionals as well as patients.
Requirements of Article 5 state that for devices with a defined expiry date, the manufacturer must keep eIFU available for 10 years after the last device has been placed on the market. For devices without expiry date and implantable devices, 15 years.
Security is a critical component of the IFUcare eIFU System. IFUcare performs quarterly OWASP scans and annual penetration testing.
